FDA.reportPublic FDA data

Application 207835

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET, ORALLY DISINTEGRATING;ORALEQ 5MG BASENoNo
002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-268Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-268Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-268Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-269Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-269Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-269Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
71205-398Rizatriptan BenzoateRizatriptan BenzoateProficient Rx LPANDACurrent